St Jude Medical’s ViewFlex Xtra catheter receives EU approval

St Jude Medical has been granted European regulatory clearance for the ViewFlex Xtra intracardiac echocardiography catheter, following on from its US approval last year.

The medical device has earned CE Mark accreditation and is designed to provide additional control and manoeuvrability during complex cardiac ablation procedures.

It features a four-way directional tip, auto-lock steering and can be paired with the ViewMate Z Intracardiac Ultrasound Console, allowing a patient's cardiac anatomy to be visualised in real time.

To be inserted in the body through a small incision in the femoral vein and guided to the heart, the catheter can be operated single-handed  to minimise the need for repositioning.

Frank Callaghan, president of the cardiovascular and ablation technologies division at St Jude Medical, said: "The combination of the ViewFlex Xtra ICE Catheter and ViewMate Z Intracardiac Ultrasound Console in an integrated EP Lab yields exceptional images … [and] allows physicians to focus on the patient and less on catheter manipulation."

This comes after the company commenced enrolment for a new clinical study last month assessing the benefits of a new method of stent-based treatment for coronary artery disease that utilises its PressureWire Aeris wireless interventional tool.